BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 6103315 · Received November 15, 2016

    Report

    Report Number
    3012307300-2016-00341
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: IT WAS INITIALLY REPORTED AS (B)(6) 2013 AND IT WAS THEN REPORTED THAT THE EVENT OCCURRED "OVER A 2 YEAR SPAN." LOT NUMBER: POTENTIAL LOT NUMBER 76X116. EXPIRATION DATE: POTENTIAL EXPIRATION DATE: 07/28/2021. POTENTIAL DEVICE MANUFACTURER DATE: 07/20/2016. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEO® 90 INFUSION SET CAUSED IRRITATION AT THE INFUSION SITE AFTER TWO DAYS. THE PATIENT NOTED THAT SHE HAD MRSA AND MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE PATIENT'S BLOOD GLUCOSE WAS REPORTED TO BE AT 500MG/DL. MULTIPLE DAILY INSULIN INJECTIONS WERE USED TO CORRECT THE HIGH BLOOD GLUCOSE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2016-00339, 3012307300-2016-00340, 3012307300-2016-00342, 3012307300-2016-00343, AND 3012307300-2016-00344.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755173 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention